CancerONCOVID-21NCT04510454
Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19
A study testing Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR in people with Cancer and COVID, run by Centre Leon Berard at 1 site in France.
Trial summary
Evaluation of the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2020to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Age ≥ 18 years on the day of signing informed consent.
- Confirmed diagnosis of any type of solid or hematologic tumor.
- Ongoing anticancer treatment at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure).
- Suspicion of COVID-19 infection. Patients must not have underwent diagnostic test and/or chest imaging before inclusion.
- Covered by a medical/health insurance.
- Signed and dated IRB/ICE approved informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test).
Read the detailed description
The Bio-Rad SARS-CoV-2 ddPCR Test is a reverse transcription (RT) droplet digital polymerase chain reaction (ddPCR) test designed to detect RNA from SARS-CoV-2 in specimens (mainly nasopharyngeal, anterior nasal, oropharyngeal and mid-turbinate swab but also nasopharyngeal wash/aspirate and nasal aspirate specimens) collected from individuals who are suspected of COVID-19 infection.
This single assay multiplex test enables a one-well reaction with three sets of the oligonucleotide primers and probes which were reported by CDC. Two were selected from regions of the virus nucleocapsid (N) gene. An additional primer/probe included in the panel is set to detect the human RNase P gene (RP) in control samples and clinical specimens.
RNA isolated and purified from swab specimens is added to the mastermix comprised of reverse transcriptase whereby RNA is converted into cDNA and then amplified, using the Bio-Rad One-Step RT-ddPCR Advanced Kit for Probes.
Briefly, the sample and mastermix RT-ddPCR mixtures are fractionated into up to 20,000 nanoliter-sized droplets in the form of a water-in-oil emulsion. The 96-well RT-ddPCR ready plate containing droplets is sealed with foil using a plate sealer. The emulsions are then thermocycled to achieve reverse transcription to generate cDNA followed by target amplification plus probe hydrolysis in each droplet. After thermocycling is complete, the 96-well RT-ddPCR ready plate is loaded into the Droplet Reader. The Droplet Reader singulates the droplets and flows them past a two-color fluorescence detector (FAM and HEX) in order to determine which contain target (positive) and which do not (negative) for each of the targets identified with the SARS-CoV-2 ddPCR Test: N1, N2 and RP. The ddPCR system uses the QuantaSoft 1.7 and QuantaSoft Analysis Pro 1.0 for analysis software.
- Being tested
- Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR
- Keywords
- COVID-19, SARS-CoV-2, ddPCR, cancer, serology
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCRDiagnostic test
Nasopharyngeal and throat/oropharyngeal swabs analyzed by both RT-PCR and ddPCR
| Study group | Role | What they receive |
|---|---|---|
| RT-PCR and ddPCR sampling analyses | Experimental | Nasopharyngeal and throat/oropharyngeal swabs analyzed by both RT-PCR and ddPCR Receives: Diagnostic Test: Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection
Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test)
Measured: At inclusion
Secondary outcomes (8)
To determine the RT-qPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection
Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard
Measured: Third week after inclusion
To determine the ddPCR and RT-qPCR abilities to detect the SARS-CoV-2 in oropharyngeal samples of symptomatic patients with suspected COVID-19 infection
Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard
Measured: Third week after inclusion
To determine the ability of a clinical diagnosis based both on patients' symptoms and chest CT-scan to detect the SARS-CoV-2 in symptomatic patients with suspected COVID-19 infection
Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard
Measured: Third week after inclusion
To determine the agreements between nasopharyngeal samples and oropharyngeal samples
Using ddPCR and RT-qPCR assays
Measured: At inclusion
To determine the agreements between a clinical diagnosis and ddPCR and RT-qPCR assays
Using ddPCR and RT-qPCR assays
Measured: At inclusion
To assess the 28-day mortality rate
Rate calculated from the date of the first diagnostic procedure to the date of death of any cause
Measured: Up to the follow-up end (28 days after inclusion)
To determine potential predictive factors of death among patients' characteristics
Demographics, type of tumor, type of anticancer, treatment, comorbidities, biological parameters
Measured: Up to the follow-up end (28 days after inclusion)
To evaluate the over risk of death of patients COVID+ versus COVID-
After adjusting on main clinical characteristics and treatment type
Measured: Up to the follow-up end (28 days after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start2 Nov 2020
- Primary completion24 Jun 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Nasopharyngeal and oropharyngeal samples will be analyzed by the standard RT-qPCR test and the ddPCR assay.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bénédicte MASTROIANNI, MD, Principal investigator, Centre Léon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510454
- Sponsor's protocol ID
- ONCOVID-21 - ET20-118
- Acronym
- ONCOVID-21
- Status last verified
- Dec 2022
- First submitted
- 11 Aug 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19
- ClinicalTrials.gov ID
- NCT04510454
- Acronym / sponsor ID
- ONCOVID-21 / ONCOVID-21 - ET20-118
- Keywords
- COVID-19, SARS-CoV-2, ddPCR, cancer, serology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test).
Detailed description
The Bio-Rad SARS-CoV-2 ddPCR Test is a reverse transcription (RT) droplet digital polymerase chain reaction (ddPCR) test designed to detect RNA from SARS-CoV-2 in specimens (mainly nasopharyngeal, anterior nasal, oropharyngeal and mid-turbinate swab but also nasopharyngeal wash/aspirate and nasal aspirate specimens) collected from individuals who are suspected of COVID-19 infection.
This single assay multiplex test enables a one-well reaction with three sets of the oligonucleotide primers and probes which were reported by CDC. Two were selected from regions of the virus nucleocapsid (N) gene. An additional primer/probe included in the panel is set to detect the human RNase P gene (RP) in control samples and clinical specimens.
RNA isolated and purified from swab specimens is added to the mastermix comprised of reverse transcriptase whereby RNA is converted into cDNA and then amplified, using the Bio-Rad One-Step RT-ddPCR Advanced Kit for Probes.
Briefly, the sample and mastermix RT-ddPCR mixtures are fractionated into up to 20,000 nanoliter-sized droplets in the form of a water-in-oil emulsion. The 96-well RT-ddPCR ready plate containing droplets is sealed with foil using a plate sealer. The emulsions are then thermocycled to achieve reverse transcription to generate cDNA followed by target amplification plus probe hydrolysis in each droplet. After thermocycling is complete, the 96-well RT-ddPCR ready plate is loaded into the Droplet Reader. The Droplet Reader singulates the droplets and flows them past a two-color fluorescence detector (FAM and HEX) in order to determine which contain target (positive) and which do not (negative) for each of the targets identified with the SARS-CoV-2 ddPCR Test: N1, N2 and RP. The ddPCR system uses the QuantaSoft 1.7 and QuantaSoft Analysis Pro 1.0 for analysis software.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nasopharyngeal and oropharyngeal samples will be analyzed by the standard RT-qPCR test and the ddPCR assay.
| Arm | Type | Receives |
|---|---|---|
| RT-PCR and ddPCR sampling analyses | Experimental | Diagnostic Test: Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCRNasopharyngeal and throat/oropharyngeal swabs analyzed by both RT-PCR and ddPCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCRNasopharyngeal and throat/oropharyngeal swabs analyzed by both RT-PCR and ddPCR | Diagnostic test | RT-PCR and ddPCR sampling analyses |
Primary outcome
To determine the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection
Time frame: At inclusion
Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test)
8 secondary outcomes
To determine the RT-qPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection
Time frame: Third week after inclusion
To determine the ddPCR and RT-qPCR abilities to detect the SARS-CoV-2 in oropharyngeal samples of symptomatic patients with suspected COVID-19 infection
Time frame: Third week after inclusion
To determine the ability of a clinical diagnosis based both on patients' symptoms and chest CT-scan to detect the SARS-CoV-2 in symptomatic patients with suspected COVID-19 infection
Time frame: Third week after inclusion
To determine the agreements between nasopharyngeal samples and oropharyngeal samples
Time frame: At inclusion
To determine the agreements between a clinical diagnosis and ddPCR and RT-qPCR assays
Time frame: At inclusion
To assess the 28-day mortality rate
Time frame: Up to the follow-up end (28 days after inclusion)
To determine potential predictive factors of death among patients' characteristics
Time frame: Up to the follow-up end (28 days after inclusion)
To evaluate the over risk of death of patients COVID+ versus COVID-
Time frame: Up to the follow-up end (28 days after inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bénédicte MASTROIANNI, MD principal investigator
Centre Léon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR in people with Cancer and COVID, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.